Compass Pathways to Submit FDA New Drug Application for COMP360 Within Two Weeks
Compass Pathways (CMPS) announced during its third-quarter 2026 earnings call that it will complete a rolling New Drug Application (NDA) submission to the FDA within two weeks. The company is seeking approval for COMP360, a synthetic psilocybin candidate designed to treat treatment-resistant depression (TRD), targeting an estimated 4 million patients in the U.S. The company aims for a commercial launch in 2027, supported by high prescriber interest and existing interventional psychiatry clinic infrastructure. With $444 million in cash on hand as of September 30, 2026, Compass Pathways maintains a sufficient financial runway to fund operations and the initial product rollout through 2028.
Tickers: $CMPS
Topics: Clinical Trials New Drug Application Pharmaceuticals Treatment-Resistant Depression
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Part of the story Compass Pathways to Submit FDA New Drug Application for COMP360 Within Two Weeks (3 articles)